Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy

Crohn Disease Clinical Trial

Official title:

A Multi-Center Retrospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019016
• Other study ID #: ISI-dVRC-001
• Status: Completed
• Phase: N/A
• First received: August 29, 2016
• Last updated: October 24, 2017
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to retrospectively compare the perioperative and short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal anastomosis in minimally invasive right colectomies for benign and malignant disease.

The secondary objective of this study is to retrospectively compare the rates of incisional hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.

Description:

This is a multi-center, retrospective chart review study of all consecutive cases of right colectomy performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of right colectomy performed with intracorporeal or extracorporeal anastomoses or via laparoscopic or robotic platforms that meet the study inclusion and exclusion criteria, will be considered for inclusion. The chart review will be performed in a reverse chronological order starting at a minimum of 30 days prior to IRB approval of the study at the site until the number of robotic-assisted and laparoscopic cases to be included per surgeon has been met. Study initiation at the participating site will occur once a research agreement has been executed between Intuitive Surgical and the participating Institution/Investigator and IRB approval has been obtained.

It is anticipated that the retrospective chart review will span the period between January 1, 2010 through 30-days prior to IRB approval of the study in 2016. Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes, and incisional hernia data will be obtained from hospital records for a total of up to approximately 1000 robotic and laparoscopic cases, among the 4 subgroups: robotic-assisted right colectomy with intracorporeal anastomosis (RRCIA), robotic-assisted right colectomy with extracorporeal anastomosis (RRCEA), laparoscopic right colectomy with intracorporeal anastomosis (LRCIA) and laparoscopic right colectomy with extracorporeal anastomosis (RRCEA). Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Patients with benign or malignant right colon disease

• Patients who have undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse colon

Exclusion Criteria:

• Patients with perforated, obstructing or locally invasive neoplasm (T4b)

• Emergency procedures

• Patients undergoing right colectomy as a secondary procedure

• Patients undergoing radiation therapy for malignant neoplasia before and after procedure

Related Conditions & MeSH terms

• Colonic Neoplasms
• Crohn Disease

Intervention

Procedure:
• Right Colectomy
Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chart review on PeriOperative Information	Number of complications observed intraoperatively through 30-days	Intraoperative through 30-days follow-up
Secondary	Chart review on Postoperative Information	Number of complications observed postoperatively through 6 month	Postoperative through 6 month follow-up